Agnostic Therapy in Rare Solid Tumors

Registration Number
NCT06638931
Lead Sponsor
Instituto do Cancer do Estado de São Paulo
Brief Summary

The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.
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Detailed Description

The ANTARES study is a phase II "basket" trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors. A "basket" trial is an innovative type of clinical trial where patients with different types of cancers, but sharing a common molecular feature (in this case, PD-...

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
28
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Single-Arm Efficacy StudyNivolumabTreatment will be administered with intravenous nivolumab at a dose of 480 mg every 4 weeks. Treatment will continue until limiting toxicity, disease progression, or for a maximum of 12 months as maintenance if the individual achieves stable disease, partial response, or complete response.
Primary Outcome Measures
NameTimeMethod
Primary Objective2 years

Overall survival (in months) of patients with advanced or metastatic rare malignancies and CPS ≥ 10 following disease progression after prior treatments while receiving the anti-PD1 antibody Nivolumab.

Primary Endpoint2 years

The primary outcome of the study is the disease control rate (DCR) based on imaging, considering the best response to treatment. A response rate of 5% will be considered non-promising, and a response rate of 25% will be considered promising. The study follows Simon's two-stage design, with type I error (alpha) set at 0.05 and type II error (beta) at 0.10. In...

Secondary Outcome Measures
NameTimeMethod
Objective Response Rate (ORR)2 years

Percentage of patients with a tumor size reduction, measured according to RECIST criteria.

Subgroup Analysis Based on PD-L1 Expression and CPS:2 years

PD-L1 Expression: Proportion of patients showing PD-L1 positivity. CPS Subgroups: Proportion of patients with CPS between 10-20 and those with CPS \> 20.

Correlation of Clinical Outcomes with Biomarker Assessments2 years

Microvesicle Analysis: Correlation between clinical outcomes and levels of circulating microvesicles.

Serum Multiplex Panel: Correlation between clinical outcomes and serum biomarker levels (e.g., cytokines, chemokines), measured in concentration units (e.g., pg/mL).

Overall Survival (OS)2 years

Time from treatment initiation to death from any cause, measured in months.

Progression-Free Survival (PFS)2 years

Time from treatment initiation to disease progression or death, whichever occurs first, measured in months.

Trial Locations

Locations (8)

Hospital São Rafael

🇧🇷

Salvador, Bahia, Brazil

Hospital São Carlos

🇧🇷

Fortaleza, Ceará, Brazil

Hospital Santa Cruz

🇧🇷

Curitiba, Paraná, Brazil

IDOR Recife

🇧🇷

Recife, Pernambuco, Brazil

Instituto D'or de Pesquisa e Ensino

🇧🇷

Sao Paulo, SP, Brazil

Instituto do Câncer do Estado de São Paulo - ICESP

🇧🇷

São Paulo, SP, Brazil

DF Star

🇧🇷

Brasília, Brazil

Instituto D'Or de Pesquisa e Ensino

🇧🇷

Rio De Janeiro, Brazil

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